Cleared Traditional

K994159 - HMP CONTROLS (TAS) RAPIDPOINT

K994159 is the FDA 510(k) clearance for HMP CONTROLS (TAS) RAPIDPOINT by Cardiovascular Diagnostics, Inc.. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K994159 · Cardiovascular Diagnostics, Inc. · Hematology device
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Feb 2000
Decision
68d
Days
Class 2
Risk

K994159 is an FDA 510(k) clearance for the HMP CONTROLS (TAS) RAPIDPOINT. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on February 15, 2000 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiovascular Diagnostics, Inc. devices

Submission Details

510(k) Number K994159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1999
Decision Date February 15, 2000
Days to Decision 68 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 113d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GGN Plasma, Coagulation Control

All 56
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K994159.
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)
K021022 · Instrumentation Laboratory CO · May 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
K021023 · Instrumentation Laboratory CO · May 2002
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
K012722 · Bio-Rad · Sep 2001
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
K992829 · Medical Analysis Systems, Inc. · Nov 1999
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
K990858 · Bio-Rad · Apr 1999
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
K981248 · Sigma Diagnostics, Inc. · Apr 1998